Job Summary

The Quality Assurance Specialist is responsible for supporting the implementation and maintenance of the Quality Management System (QMS), ensuring compliance with applicable GMP/GSP requirements, and supporting quality activities across local operations.

The role works closely with cross-functional teams and external suppliers to manage quality risks, audits, inspections, product quality issues, deviations, CAPA, and other quality-related activities in accordance with internal procedures and regulatory requirements.

Key Responsibilities

1. Quality Assurance, Inspections & Internal Audit

• Support the timely implementation and maintenance of applicable Quality Management Systems (QMS), SOPs and Work Instructions within local operations.
• Support the implementation and maintenance of initial and ongoing quality training programs for relevant employees.
• Support the management and documentation of planned, permanent and temporary changes related to GMP/GSP activities and systems, ensuring actions are completed within agreed timelines.
• Collect and monitor key Quality Performance Indicators (KPIs), identify significant trends and support the development of appropriate actions.
• Support and participate in Quality Review Meetings as required.
• Support the preparation and coordination of Health Authority inspections and internal quality audits covering GMP/GSP activities.
• Work with cross-functional teams to develop appropriate action plans in response to audit/inspection findings, and track implementation through completion.
• Participate in self-inspection programs as an auditor and/or auditee, as required.
• Participate in Quality Risk Management (QRM) activities, including the identification, assessment, documentation and communication of risks related to product quality and patient safety.

2. Product Quality & Local Product Disposition

• Support the local product release process in accordance with applicable distribution licenses, procedures and regulatory requirements.
• Coordinate product repackaging and/or relabelling activities conducted internally or through third-party packaging sites.
• Review and approve relevant documentation associated with repackaging and relabelling activities, where applicable.
• Support the management of quarantine alerts and shipments, ensuring activities are handled in compliance with established procedures.
• Provide support for market action activities, including product withdrawal or other quality-related actions, as required.
• Support product complaint handling, including complaint intake, triage, documentation and communication with relevant stakeholders.
• Act as a contact point for relevant regulatory authorities and/or reporters regarding product quality matters, as required.
• Participate in deviation investigations, applying appropriate investigation tools and working with cross-functional teams to implement corrective and preventive actions.
• Escalate significant quality concerns or deviations that may have an impact on product quality or patient safety.
• Support the preparation and implementation of actions arising from Quality Review Team (QRT) meetings, where required.
• Support the management and timely closure of relevant Corrective and Preventive Actions (CAPA).

3. Supplier Quality Management

• Execute quality activities related to the management of GxP suppliers, including supplier qualification and ongoing quality oversight in accordance with internal and regulatory requirements.
• Support the implementation of appropriate customer screening and compliance processes in line with applicable company and local regulatory requirements.
• Support the coordination of supplier quality audits and follow-up actions, as required.
• Monitor supplier-related quality actions and ensure agreed corrective actions are completed within defined timelines.

4. Quality & Cross-functional Collaboration

• Support the development and execution of quality-related objectives and projects aligned with the organization's quality strategy.
• Contribute to the development and maintenance of a strong quality culture within the team and organization.
• Collaborate effectively with cross-functional teams and external stakeholders to ensure quality requirements are understood and consistently implemented.
• Provide support and guidance on quality-related matters within the assigned scope.

Key Performance Indicators (KPIs)

• Compliance with applicable SOPs, Work Instructions and Quality Management Systems.
• Timely management and closure of deviations, CAPA, change controls, complaints and regulatory commitments.
• Effective implementation and closure of Quality Management System activities with minimal overdue actions.
• Effective management and follow-up of supplier quality activities.
• Successful preparation for and management of internal and external inspections/audits, with no critical or repeat findings.
• Timely and accurate completion of product quality reporting and regulatory submissions, where applicable.

Qualifications

Education

• Bachelor's degree or higher in Pharmacy, Science or a related discipline.

Experience

• Minimum 2 years of experience in the pharmaceutical industry, preferably in a Quality Assurance, Quality Compliance or Quality Systems role.
• Hands-on experience with GMP, GSP and/or GDP requirements.
• Experience in Quality Management Systems (QMS).
• Experience in audit/inspection preparation and follow-up.
• Experience with deviation investigation, CAPA and change control.
• Experience in technical writing and quality reporting.
• Experience working with cross-functional stakeholders and external parties.
• Experience in supplier quality management or GxP supplier oversight is an advantage.

Languages

• Fluent English, both written and verbal.

Computer Skills

• Strong proficiency in Microsoft Word and Excel.
• Experience working with electronic Quality Management Systems (eQMS) or document management systems.
• Experience with quality management platforms such as TrackWise® is an advantage.

Core Competencies

• GMP/GSP/GDP Knowledge: Strong understanding and practical application of relevant GxP requirements.
• Quality & Compliance: Ability to ensure activities are conducted in accordance with applicable procedures and regulations.
• Auditing: Understanding of audit and inspection processes.
• Technical Writing: Ability to prepare clear, structured and accurate quality reports and documentation.
• Analytical & Problem-Solving Skills: Ability to identify root causes, assess risks and develop effective solutions.
• Ownership & Accountability: Takes responsibility for assigned activities and follows through to completion.
• Communication & Influencing: Able to communicate effectively and influence stakeholders across different functions.
• Decision-Making: Able to make timely, well-informed decisions based on analysis, experience and sound judgment.
• Planning & Organization: Able to prioritize multiple activities and manage deadlines effectively.
• Adaptability: Comfortable working with changing priorities, ambiguity and complex situations.
• Emotional Intelligence: Demonstrates self-awareness and the ability to understand and respond appropriately to others.
• Initiative: Proactively identifies issues and opportunities for improvement while maintaining quality standards.